Senior Clinical Research Associate
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate based in Canada.
This role offers the opportunity to play a key part in advancing clinical development programs that directly contribute to improving patient outcomes worldwide.
You will act as a critical link between clinical trial sites and study operations, ensuring that studies are conducted in compliance with protocol requirements, ICH-GCP standards, and applicable regulatory guidelines.
The position involves extensive collaboration with investigators and site teams to support study execution, resolve operational challenges, and maintain high-quality data integrity.
You will take ownership of site performance across all study phases, from initiation through close-out, while ensuring timely delivery of milestones and study objectives.
Working in a dynamic, matrixed environment, you will contribute to both onsite and remote monitoring activities, supporting global clinical trials with precision and accountability.
This role is well-suited for a proactive clinical research professional who thrives in a fast-paced, quality-driven environment and is passionate about advancing healthcare innovation.
Accountabilities:
- Serve as the primary point of contact for assigned clinical trial sites, ensuring protocol adherence, operational compliance, and high-quality study execution from initiation through close-out.
- Conduct site visits (qualification, initiation, monitoring, and close-out) as well as remote contacts to evaluate site performance, resolve issues, and support ongoing study activities.
- Build and maintain strong relationships with investigators and site staff while providing training, guidance, and ongoing support to ensure regulatory and procedural compliance.
- Monitor and ensure data integrity by reviewing CRFs, resolving queries, tracking SAEs, and addressing any data quality concerns in collaboration with site teams.
- Oversee site documentation, including regulatory files and TMF contributions, ensuring audit and inspection readiness at all times.
- Assess site recruitment strategies, study progress, and performance, recommending corrective actions and improvements where needed.
- Ensure compliance with ICH-GCP, local regulations, and study-specific procedures while identifying and escalating risks impacting timelines or data quality.
- Solid experience in site management or clinical research, with strong understanding of clinical trial methodology, regulatory frameworks, and ICH-GCP guidelines.
- Degree in biological sciences, pharmacy, nursing, or a related health discipline, or equivalent professional experience.
- Strong ability to work independently, manage priorities, and make sound decisions in a fast-paced, matrixed environment.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to interact effectively with clinical sites and internal teams.
- Strong analytical, problem-solving, and attention-to-detail skills with a focus on data quality and compliance.
- Proficiency with clinical systems such as CTMS, EDC, and electronic document management tools, along with MS Office applications.
- Willingness to travel extensively as required by study demands and site monitoring activities.
- Opportunity to contribute directly to global clinical research programs improving patient care and treatment outcomes.
- Flexible remote-first working model with travel to clinical sites as required.
- Exposure to international studies and collaboration with global clinical teams and experts.
- Career development opportunities within a leading clinical research environment.
- Dynamic, collaborative, and quality-focused work culture with strong emphasis on professional growth.
- Competitive compensation package aligned with experience and responsibilities.